NCT07150767

A Clinical Study to Explore the Safety, Tolerability, and Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) Combined With Neoadjuvant Treatment for Locally Advanced Breast Cancer

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Beijing Bio-Targeting Therapeutics Technology Co., Ltd · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A clinical study to explore the safety, tolerability, and efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTTT001) combined with neoadjuvant treatment for locally advanced breast cancer.This study is a single-arm, open-label, single-center dose-escalation and expansion trial.

Detailed description

Three study drug dose groups were preset, namely 5×10\^10VP、2×10\^11VP and 5×10\^11VP and the "3+ 3" dose escalation method was adopted according to the principle of dose escalation and the sequential principle from low to high.In order to protect the safety of subjects, in theory, in order to protect the safety of subjects, the second subject can be enrolled at least 2 weeks after the administration of the first subject in each dose group at least 2 weeks after administration in the DLT observation phase of the same dose group. The DLT observation period for each subject is 21 days after the first dose, and the next dose escalation can only be entered after the last subject in each dose group completes the DLT observation period. At least 3 subjects were enrolled in each dose group, and each subject received only one corresponding dose.

Conditions

• Locally Advanced Breast Cancer (LABC)

Interventions

Type	Name	Description
BIOLOGICAL	BioTTT001 injection	BioTTT001 is administered as a multiple Intratumoral injection. The dose groups to be infusion were 5.0×10\^10 viral particle (VP) ,2.0×10\^11 VP and 5×10\^11 VP based on the 3+3 dose escalation principle.

Timeline

• Start date: 2025-03-26
• Primary completion: 2027-03-26
• Completion: 2027-03-26
• First posted: 2025-09-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: China